Electronic Muscle Stimulators

Electronic muscle stimulators (EMS) use minute electrical currents to stimulate muscles to contract and to relax. The chemical changes that subsequently take place mimic those that occur during normal exercise. Because EMS machines are marketed as toning, reshaping and firming devices for one's abdominals, buttocks, obliques and thighs, they are very popular among consumers who are looking for an alternative to strenuous exercise. Athletes use EMS machines to build power and strength. Doctors usually prescribe the devices as a last resort for muscle problems such as spasms, aches and pains.

Electrical muscle stimulators are considered devices under the Federal Food, Drug, and Cosmetic Act. Under this law, the U.S Food and Drug Administration (FDA) is responsible for regulating the sale of all electrical muscle stimulators in the United States. Therefore, firms must comply with appropriate FDA premarket regulatory requirements before they can legally sell their stimulators. Most electrical muscle stimulators that have been reviewed by the FDA are intended for use in physical therapy and rehabilitation under the direction of a health care professional. If a company wants to sell EMS devices directly to consumers, the company needs to show the FDA it can be used safely and effectively in that setting.

The FDA has received reports of shocks, burns, bruising, skin irritation, and pain associated with the use of some of these devices. There have been a few recent reports of interference with implanted devices such as pacemakers and defibrillators. Some injuries required hospital treatment. It is very important that these devices be properly designed, manufactured, and labeled with clear and complete instructions for use and that anyone using them follows the instructions carefully. The FDA is also concerned because many of these devices have cables and leads. If those cables and leads do not comply with electrical safety standards, there is the possibility of electrocution by users and other household members.

Electrical muscle stimulators that have not met FDA premarket requirements are illegal, and the FDA has not determined whether they are properly designed, manufactured, and labeled to provide reasonable assurance that they are safe and effective. The FDA is currently investigating firms that are illegally marketing EMS devices.

If you have been seriously injured by an electronic muscle stimulator, it may be important for you to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

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